Adverse-event reports (MAUDE)
Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
106 linked reportsMalfunction 98Injury 7Other 1
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 2 |
| 2019-02 | 0 | 1.8 |
| 2019-03 | 0 | 4.33 |
| 2019-04 | 1 | 4.33 |
| 2019-05 | 2 | 4.67 |
| 2019-06 | 5 | 3.5 |
| 2019-07 | 2 | 2 |
| 2019-08 | 2 | 3.67 |
| 2019-09 | 0 | 2 |
| 2019-10 | 3 | 3.5 |
| 2019-11 | 1 | 1 |
| 2019-12 | 0 | 1.67 |
| 2020-01 | 0 | 2.4 |
| 2020-02 | 3 | 2 |
| 2020-03 | 2 | 3.8 |
| 2020-04 | 2 | 2.83 |
| 2020-05 | 0 | 1 |
| 2020-06 | 4 | 4.5 |
| 2020-07 | 1 | 4 |
| 2020-08 | 1 | 1.71 |
| 2020-09 | 0 | 3.75 |
| 2020-10 | 0 | 4 |
| 2020-11 | 0 | 7 |
| 2020-12 | 1 | 2.17 |
| 2021-01 | 1 | 2.2 |
| 2021-02 | 2 | 4 |
| 2021-03 | 7 | 4.5 |
| 2021-04 | 3 | 3.6 |
| 2021-05 | 2 | 3.17 |
| 2021-06 | 4 | 6 |
| 2021-07 | 0 | 13 |
| 2021-08 | 3 | 4.25 |
| 2021-09 | 1 | 6 |
| 2021-10 | 0 | 1.67 |
| 2021-11 | 5 | 3.5 |
| 2021-12 | 3 | 7.5 |
| 2022-01 | 0 | 1 |
| 2022-02 | 0 | 2.5 |
| 2022-03 | 0 | 4.25 |
| 2022-04 | 0 | 2.75 |
| 2022-05 | 0 | 2.67 |
| 2022-06 | 1 | 2.5 |
| 2022-07 | 0 | 4.33 |
| 2022-08 | 0 | 2.25 |
| 2022-09 | 0 | 2 |
| 2022-10 | 1 | 2.5 |
| 2022-11 | 0 | 2.67 |
| 2022-12 | 0 | 2 |
| 2023-01 | 0 | 6.5 |
| 2023-02 | 1 | 1.8 |
| 2023-03 | 2 | 2 |
| 2023-04 | 1 | 1.5 |
| 2023-05 | 0 | 7.5 |
| 2023-06 | 1 | 1.75 |
| 2023-07 | 2 | 2 |
| 2023-08 | 1 | 1.8 |
| 2023-09 | 1 | 1.33 |
| 2023-10 | 0 | 2 |
| 2023-11 | 2 | 2.33 |
| 2023-12 | 0 | 2 |
| 2024-01 | 2 | 4 |
| 2024-02 | 1 | 2.83 |
| 2024-03 | 0 | 1.67 |
| 2024-04 | 4 | 3.33 |
| 2024-05 | 2 | 1.67 |
| 2024-06 | 0 | 1 |
| 2024-07 | 2 | 2.75 |
| 2024-08 | 2 | 4.33 |
| 2024-09 | 0 | 8 |
| 2024-10 | 0 | 3 |
| 2024-11 | 0 | 3.33 |
| 2024-12 | 1 | 3 |
| 2025-01 | 3 | 4.33 |
| 2025-02 | 0 | 3.67 |
| 2025-03 | 0 | 1.5 |
| 2025-04 | 1 | 3 |
| 2025-05 | 2 | 3 |
| 2025-06 | 1 | 2.67 |
| 2025-07 | 0 | 3 |
| 2025-08 | 0 | 1 |
| 2025-09 | 0 | 2 |
| 2025-10 | 4 | 2.67 |
| 2025-11 | 1 | 3.67 |
| 2025-12 | 2 | 2.25 |
| 2026-01 | 0 | 3.67 |
| 2026-02 | 0 | 3 |
| 2026-03 | 0 | 3.5 |
| 2026-04 | 3 | 2.5 |
| 2026-05 | 0 | 16 |
| 2026-06 | 1 | 3.33 |
Failure-mode summaryAI-generated
40 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-06-04 | 1320894-2026-00137 | Malfunction | Available | catalog number |
| 2026-04-14 | 1320894-2026-00102 | Malfunction | Available | exact di |
| 2026-04-09 | 24829282 | Malfunction | Available | catalog number |
| 2025-12-19 | 1320894-2025-00288 | Malfunction | Available | catalog number |
| 2025-11-14 | 1320894-2025-00260 | Malfunction | Available | exact di |
| 2025-10-30 | 23425258 | Malfunction | Available | catalog number |
| 2025-10-09 | 1320894-2025-00237 | Injury | Available | exact di |
| 2025-06-05 | 1320894-2025-00147 | Malfunction | Available | exact di |
| 2025-05-07 | 21975757 | Malfunction | Available | catalog number |
| 2025-04-08 | 1320894-2025-00099 | Malfunction | Available | exact di |
| 2025-01-31 | MW5165585 | Malfunction | Available | catalog number |
| 2025-01-27 | 21242571 | Malfunction | Available | catalog number |
| 2024-12-05 | MW5163359 | Malfunction | Available | model number |
| 2024-08-29 | MW5159080 | Malfunction | Available | catalog number |
| 2024-07-24 | 1320894-2024-00182 | Injury | Available | exact di |
Showing the most recent 72 of 106 linked reports.
Showing 1–15 of 72
Regulatory clearances
- 510(k)K142716Substantially equivalent (SESE) · 2015-02-10clearance family
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2026-05-13 | NAI | No action indicated | Biorez, Inc | 0 |
| 2026-04-06 | VAI | Voluntary action indicated | ConMed Corporation | 6 |
| 2026-04-06 | VAI | Voluntary action indicated | ConMed Corporation | 6 |
| 2023-12-14 | NAI | No action indicated | Linvatec Corp. | 0 |
| 2023-08-04 | VAI | Voluntary action indicated | Biorez, Inc | 1 |
| 2022-11-10 | NAI | No action indicated | ConMed Corporation | 0 |
| 2022-11-10 | NAI | No action indicated | ConMed Corporation | 0 |
| 2022-07-13 | NAI | No action indicated | ConMed Corporation | 0 |
| 2022-07-13 | NAI | No action indicated | ConMed Corporation | 0 |
| 2020-09-22 | VAI | Voluntary action indicated | ConMed Corporation | 0 |
| 2020-09-22 | VAI | Voluntary action indicated | ConMed Corporation | 0 |
| 2019-10-17 | NAI | No action indicated | ConMed Corporation | 0 |
| 2019-10-17 | NAI | No action indicated | ConMed Corporation | 0 |
| 2017-02-03 | VAI | Voluntary action indicated | ConMed Corporation | 2 |
| 2017-02-03 | VAI | Voluntary action indicated | ConMed Corporation | 2 |
| 2017-01-23 | NAI | No action indicated | Conmed | 0 |
| 2016-02-03 | VAI | Voluntary action indicated | ConMed Corporation | 5 |
| 2016-02-03 | VAI | Voluntary action indicated | ConMed Corporation | 5 |
| 2014-11-18 | NAI | No action indicated | ConMed Corporation | 0 |
| 2014-11-18 | NAI | No action indicated | ConMed Corporation | 0 |
| 2014-01-29 | WL | Warning Letter | ConMed Corporation | — |
| 2014-01-29 | WL | Warning Letter | ConMed Corporation | — |
Similar devices
- 1 HSG/SIS Tray No Catheter TITUS MEDICAL LLC
- 10 HSG/SIS Procedure Trays TITUS MEDICAL LLC
- ABBI Coopersurgical, Inc.
- ABBI Coopersurgical, Inc.
- AESCULAP Aesculap AG
- ALLY II UPS Coopersurgical, Inc.
- ALLY II UPS (Uterine Positioning System) Coopersurgical, Inc.
- ALLY II UPS (Uterine Positioning System) Coopersurgical, Inc.
- ALLY Uterine Positioning System® Coopersurgical, Inc.
- Adapter Drape (For RUMI II or Advincula Arch) Coopersurgical, Inc.
- Advincula Arch Reusable Manipulator Handle Coopersurgical, Inc.
- Ally UPS Adapter Drape for Advincula Delineator Coopersurgical, Inc.
Select up to two to place side-by-side with this device.